ORTHO SUPER CHOCOLATE FLUORIDE MOUTHWASH- anticavity mouthwash liquid

Ortho Super Chocolate Fluoride Mouthwash by

Drug Labeling and Warnings

Ortho Super Chocolate Fluoride Mouthwash by is a Otc medication manufactured, distributed, or labeled by SuperMouth, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT
(in each 10 mL)

Sodium Fluoride 0.02%

PURPOSE

PURPOSE
Sodium Fluoride …. Anticavity

INDICATIONS & USAGE

USE

Fluoride mouthwash

WARNINGS

WARNINGS:

Keep out of reach of children under 6 years of age.

If more than used for
rinsing is accidentally
swallowed, get medical
help or contact a
Poison Control Center
right away.

Do not use if safety seal
is broken.

DOSAGE & ADMINISTRATION

DIRECTIONS

1) Shake well before using.
2) Use daily by dispensing 10 mL, swish
    vigorously for 1 minute, and then spit out.
3) No need to rinse.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS

Water, Erythritol, Xylitol, *Hydroxamin+®
(Nano-Hydroxyapatite, Menaquinone-7
(Vit K2), Cholecalciferol (Vit D3)),
Inulin, Glycerin, Sodium Gluconate, Sodium
Bicarbonate, Methylsulfonylmethane, Natural
Flavors, Natural Benzoic Acid,Sodium
Ascorbate (Vit C), Xanthan Gum.

Product Labeling: Ortho Super Chocolate Fluoride Mouthwash

Supermouth

super chocolate

fluoride mouthwash

with hydroxamin+®

unique formulation for orthodontics that
reaches areas brushing & flossing don’t

16 fl oz (473 mL)

SuperMouth®
9737 Aero Drive
San Diego, CA 92123

(844) MOUTHCARE

res

INGREDIENTS AND APPEARANCE

ORTHO SUPER CHOCOLATE FLUORIDE MOUTHWASH 
anticavity mouthwash liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83729-111
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.002 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ERYTHRITOL (UNII: RA96B954X6)
XYLITOL (UNII: VCQ006KQ1E)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
MENAQUINONE 7 (UNII: 8427BML8NY)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
INULIN (UNII: JOS53KRJ01)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM ASCORBATE (UNII: S033EH8359)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	brown	Score
Shape		Size
Flavor	CHOCOLATE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83729-111-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/20/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	02/20/2024

Labeler - SuperMouth, LLC. (049384038)

Registrant - SuperMouth, LLC. (049384038)